From time to time, most younger children suffer from earaches. In many cases, an earache is caused by a build up of fluid in the middle ear that leads to an infection in the ear. Usually, the earache can be treated by giving the child an antibiotic that will help to treat this middle ear infection.
Unfortunately, antibiotics do not work well with all patients, for although the antibiotic helps to cure the infection, some patients accumulate fluid frequently enough within their middle ears so that it is necessary to take steps to aerate the middle ear to thereby help prevent the accumulation of fluid. This aeration helps to reduce the fluid and likelihood that bacteria will cause an infection in the accumulated fluid, and helps to reduce or eliminate the re-currence of earaches.
To treat such patients, a tympanostomy tube is often inserted into the eardrum to extend through the eardrum in order to keep the middle ear aerated for a prolonged period of time, and to prevent the accumulation of fluid in the inner ear. A tympanostomy tube is also know as a grommet, ear tube, pressure equalization tube, PE tube, or a myringotomy tube.
The operation to insert the tube involves a myringotomy and is performed under local or general anesthesia. A myringotomy is a surgical procedure in which a tiny incision is created in the eardrum, so as to relieve pressure caused by the excessive build up of fluid, or to drain puss, wherein a tube is inserted in the eardrum for residence over an extended period of time.
The most commonly used type of ear tube is shaped like a grommet. If a medical practitioner decides that the ear needs to be kept open and ventilated for a long period of time, a “T” shaped tube may be used, as these “T” tubes can stay in place two to four years or so. The materials of choice for creating such tubes are plastic materials such as silicone or teflon. Formerly, stainless steel tubes and other materials were popular, but are no longer used frequently.
The placement of ear tubes in a child's ear is a very common procedure. In the U.S., it is estimated that the most common reason for a child to undergo a general anesthetic is the insertion of such ear tubes within the child's ear. Ear tubes (tympanostomy tubes) generally remain within the eardrum for an extended period of time, usually lasting between six months and two years, although “T” tubes can last for four years or longer. Ear tubes generally spontaneously fall out of the eardrum as the skin of the eardrum slowly migrates out toward the ear canal wall over time. The ear drum usually closes without a residual hole at the tube site, but in a small number of cases, a perforation can exist.
In the conventional manner for performing tube insertion, first a myringotomy incision is made by inserting a needle-like knife into the ear canal to make the incision. Secondly, after the incision is made, the grommet-shaped ear tube is grasped with forceps and half of the grommet is inserted through the incision to finally rest suspended within the eardrum, so that the passageway in the grommet creates an air passage between the auditory canal and tympanic cavity.
A typical ear tube grommet is shaped similarly to a thread spool or wire spool. The grommet generally includes a reduced diameter central portion having a cylindrical radially outwardly facing surface. A first relatively enlarged diameter flange having a cylindrical radially outwardly facing perimetral edge is placed at one end of the reduced diameter portion, and a second, similarly configured enlarged diameter portion is placed at the second end of the reduced diameter portion. An axially extending passageway extends between a first end and a second end of the spool, which also includes generally planar upper and lower surfaces that have a generally round shape.
When inserted in the eardrum, the first enlarged diameter portion is disposed externally of the eardrum, with the second enlarged diameter portion disposed interiorly of the eardrum. The reduced diameter central portion extends through the eardrum. The result is that the first and second enlarged diameter portions prevent the grommet-shaped tube from becoming disconnected from the eardrum, to thus hold the grommet suspended within its position within the eardrum. When held in the proper position, the axially extending passageway of the tube can pass between the inner and outer surfaces of the eardrum, to thereby provide aeration to the middle ear, which comprises that portion of the ear that is disposed just interiorly of the eardrum.
Although such ear tubes and insertion devices serve their intended purposes, room for improvement exists. In particular, the generally small size of an ear tube makes it very difficult and tricky to manipulate the tube properly to insert it into the eardrum. In particular, it is difficult for even skilled surgeons to line up the grommet properly to insert it into the very tiny incision that was recently made in the eardrum by the knife. In essence, the doctor must move the knife into and out of the ear to make the incision, and then follow it up with an insertion of the grommet into the ear, within the same incision that was just made by the knife.
It is therefore one object of the present invention to provide an ear tube and insertion device that provides the potential to provide a more smooth and easy ear tube insertion procedure than that known currently by the applicant.